FDA product code · Neurology

Agent, Injectable, Embolic

Name: FDA decisions, review times, recalls and adverse event reports for product code MFE
Creator: 510(k) Report

MFEClass IIIPMA required1 decision since 20050 recalls

1 FDA decision since 2005. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of MFE at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MFE

5in 2024

2007high 5 (2019) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MFE

Too few MFE 510(k)s in any year since 2007 to give a median.

Recalls per year · MFE

No recall names MFE since 2007.

Adverse event reports per year · MFE

177in 2025

2007high 433 (2023) · low 18 (2007)2025

MAUDE reports naming product code MFE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	18
2008	0	—	61
2009	0	—	56
2010	0	—	85
2011	0	—	97
2012	1	—	61
2013	2	—	82
2014	1	—	73
2015	1	—	238
2016	2	—	221
2017	2	—	365
2018	3	—	119
2019	5	—	119
2020	4	—	124
2021	3	—	150
2022	1	—	176
2023	1	—	433
2024	5	—	248
2025	0	—	177
2026	5	—	—

FIG. 1 — MFE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MFE? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Agent, Injectable, Embolic

What has FDA decided in MFE lately?